No of openings: 1
Experience : 3 to 5 yrs experience in Clinical Operations.
Job Description :
- Training the teams and new employees regularly and periodically.
- Negotiating the study budgets with the Principal Investigator and executing the Clinical Trial Agreement.
- Assigning and Managing the project team as per the study requirement.
- Development and Revision of departmental SOPs.
- Reviews CRA Site Visit documents (follow up letters and reports).
- Reviews and Approves the travelling plan and budgets of the monitors.
- Updating the sponsor about the progress of the study as agreed in the contract.
- Participating in telecoms with the clients and kick of meetings.
- Hosting the external audits.
- Preparing Monitoring plan for the CRA as per the study specifications and protocol and training the CRA on the same.
- Training the team on study related documents.
- Managing and coordinating all regional CRA activities.
- To perform co-monitoring visits to ensure quality of data generated
- If required accompanying the CRA’s in Qualification visit, Site Initiation Visit and Monitoring visits.
- Organize and present at Investigator Meetings/ Internal meetings.
- Development of project management plan, risk management plans.
- Review the Ethics Committee dossiers as required.
- Review of power point presentations prepared by CRA for investigator meetings, Site Initiation visits.
No of openings : 05
Job Code: CRAOO1A
Experience: 1 to 4 yrs in Clinical Research Associative.
Job Description :
- Responsible for conduct of Qualification visit, Site Initiation Visit, Monitoring Visit and Closeouts visit.
- Would be the first point of contact for Communication with the Investigators and site personnel’s for the study assigned.
- Coordinate the movement of Laboratory samples if applicable.
- Ensuring the data entry/CRF filling, following-up visits of subjects as per the protocol.
- Prepares follow up letters and reports for the respective visits as per the SOPs and share with the site and Sponsor as required.
- Follow-up with the coordinator for the query resolution.
- To collect the collated Ethics Committee documents from CTA for EC submission as defined in site SOPs.
- To ensure that the interim safety reports, interim study reports are provided to EC as per the governed regulatory body.
- Preparation of power point presentations for investigator meetings and Site Initiation visits.
- Managing the CRC activities, and training them periodically.